FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
20785–20808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2019
Avenir Muller Stem, Avenir Cemented Hip Stem
K193030 · LZO
Zimmer GmbH
Orthopedic · 37d
Cleared Dec 05, 2019
MCI - CMF System
K182758 · JEY
Mci Medical Concept Innovation, Inc.
Dental · 433d
Cleared Dec 05, 2019
G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular...
K190660 · LPH
Zimmer, Inc.
Orthopedic · 266d
Cleared Dec 05, 2019
Neodent Implant System - Temporary Abutments
K191191 · NHA
Jjgc Industria E Comercio DE...
Dental · 216d
Cleared Dec 05, 2019
Southern Implants PEEK Abutments
K191250 · NHA
Southern Implants (Pty), Ltd.
Dental · 210d
Cleared Dec 05, 2019
PICO 14 Single Use Negative Pressure Wound Therapy System
K191760 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 157d
Cleared Dec 05, 2019
TOMi Scope
K191804 · QJG
Photonicare, Inc.
Ear, Nose, Throat · 153d
Cleared Dec 05, 2019
21HK512D
K191864 · PGY
Lg Electronics.Inc
Radiology · 146d
Cleared Dec 05, 2019
Vitra 2
K191962 · GEX
Quantel Medical
Ophthalmic · 135d
Cleared Dec 05, 2019
BC Reflex Uni Knee System
K191996 · HSX
Bodycad Laboratories, Inc.
Orthopedic · 132d
Cleared Dec 05, 2019
BTL-899
K192224 · GEI
Btl
General & Plastic Surgery · 111d
Cleared Dec 05, 2019
Elekta Unity
K192482 · IYE
Elekta Limited
Radiology · 86d
Cleared Dec 05, 2019
Digital Intraoral Imaging Plate System
K192766 · MUH
Fsusen Technology Co., Ltd.
Radiology · 66d
Cleared Dec 05, 2019
MEDRAD Mark 7 Arterion Injection System
K193028 · DXT
Bayer Medical Care, Inc.
General Hospital · 36d
Cleared Dec 04, 2019
MolecuLight i:X
K191371 · QJF
Moleculight, Inc.
General & Plastic Surgery · 196d
Cleared Dec 04, 2019
RELiZORB
K191379 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 195d
Cleared Dec 04, 2019
Medline Quick Switch Valve with ENFit Connector
K191759 · PIF
Medline Industries, Inc.
Gastroenterology & Urology · 156d
Cleared Dec 04, 2019
TRACKER Kyphoplasty System
K192335 · NDN
GS Medical Co., Ltd.
Orthopedic · 98d
Cleared Dec 04, 2019
SICAT Implant V2.0
K192348 · LLZ
Sicat GmbH & Co. KG
Radiology · 97d
Cleared Dec 04, 2019
Epic 980
K192430 · GEX
Biolase, Inc.
General & Plastic Surgery · 90d
Cleared Dec 04, 2019
VenaPro Vascular Therapy System
K193020 · JOW
Innovamed Health, LLC
Cardiovascular · 35d
Cleared Dec 04, 2019
AIROS 8 Sequential Compression Device
K193068 · JOW
Airos Medical, Inc.
Cardiovascular · 30d
Cleared Dec 04, 2019
AIROS 6 Sequential Compression Device
K193069 · JOW
Airos Medical, Inc.
Cardiovascular · 30d
Cleared Dec 03, 2019
Deka Tiac 1
K183371 · PBX
El..En. Electroic Engineering Spa
General & Plastic Surgery · 362d